KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
FDA device recall Z-0543-2022 · posted 2022-01-28 · Terminated
Recall details
- Recalling firm
- Microbiologics Inc
- Reason for recall
- Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
- Action taken
- Microbiologics notified customers on about 02/24/2021 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions were to: 1. REVIEW lab procedures to understand how this information affects your usage; 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage; 3. COMPLETE the response form provided; 4. RETURN the response form to recall@microbiologics.com; 5. KEEP this letter for your records; 6. CONTACT Microbiologics if a replacement kit is needed. Questions or concerns can be directed to Recall Support team at 320.229.7073 or recall@microbiologics.com.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JTR
- Quantity affected
- 65 packs (130 units)
- Distribution
- Worldwide distribution - US distribution in the states of GA, MS, MT, NC, NM, NV, TN, TX, WA, WI and the countries of Brazil, Canada, China, Colombia, Dominican Republic, France, India, Ireland, Japan
- Date initiated
- 2021-02-24
- Date posted
- 2022-01-28
- Date terminated
- 2022-07-11
- Location
- Saint Cloud, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (K861022) | Micro-Bio-Logics | 1986-04-04 |